GOVERNMENT
-------
|
SOCIALIST
REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
-----------
|
No.: 93/2016/ND-CP
|
Hanoi,
July 01, 2016
|
DECREE
PROVIDING
FOR CONDITIONS FOR MANUFACTURE OF COSMETIC PRODUCTS
Pursuant to the Law on
Organization of the Government dated June 19, 2015;
Pursuant to the Law on Investment
dated November 26, 2014;
At the request of Minister of
Health;
The Government promulgates this Decree to provide for conditions for manufacture of
cosmetic products.
Chapter 1
GENERAL PROVISIONS
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
This Decree provides for conditions for
manufacturers of semi-finished cosmetic products, manufacturers of finished
cosmetic products and cosmetic packaging establishments (hereinafter referred
to as cosmetic manufacturers), and procedures for issuance, re-issuance,
amendment and revocation of Certificates of eligibility for cosmetic
manufacturing.
Article 2.
Interpretation of terms
In this Decree, these terms shall be
construed as follows:
1. Cosmetic product is a
substance or a preparation intended to be placed in contact with the various external parts of the human body (skin, hair system, finger nails, toenails, lips and external genital organs)
or with the teeth and the mucous membranes of the oral cavity with a
view exclusively or mainly to cleaning them, perfuming them, changing their
appearance, correcting body odours or keeping the human body in good condition.
2. Semi-finished cosmetic
product refers to a product that has not been completely manufactured, and has
to undergo one or several production stages, or packaging process to become a
finished cosmetic product.
Chaprter II
CONDITIONS FOR
MANUFACTURE OF COSMETIC PRODUCTS
Article 3.
Requirements to be satisfied by cosmetic manufacturers
1. A cosmetic manufacturer must be established under the law; and
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Article 4. Conditions
for issuance of Certificate of eligibility for cosmetic manufacturing
A cosmetic manufacturer may be qualified to apply
for a Certificate of eligibility for cosmetic manufacturing if it satisfies all
of the following conditions:
1. Personnel requirement: The
production manager must have professional knowledge about one of the following
majors: Chemistry, Biology, Pharmacy or other relevant majors in order to meet
job requirements.
2. Infrastructure requirement:
a) Its location, area, workshop and equipment must
meet requirements on the production line and types of cosmetic products which
will be produced by that manufacturer as described in the application dossier
for Certificate of eligibility for cosmetic manufacturing;
b) Raw materials, packaging materials and finished
products stores must ensure the separation between raw materials, and packaging
materials, and finished products, and have separate areas for storing flammable and explosive matters, highly
toxic substances, discharged or recalled or returned materials or products.
3. Its quality management
system must satisfy the following requirements:
a) Raw materials and auxiliary materials used to
manufacture cosmetic products must meet quality standards adopted by the
manufacturer;
b) The water used in the production of cosmetic
products must comply with the national technical regulations on drinking water
quality promulgated by Minister of Health;
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
d) The production process must be available for
each type of cosmetic products;
dd) The quality of raw materials, semi-finished
products, bulk products and finished products must be monitored by quality
control divisions;
e) Documentation system must be available.
Chaprter III
POWER, APPLICATION AND
PROCEDURES FOR ISSUANCE OF CERTIFICATES OF ELIGIBILITY FOR COSMETIC
MANUFACTURING
Article 5. Power to issue
Certificates of eligibility for cosmetic manufacturing
Departments of Health shall issue
Certificates of eligibility for cosmetic manufacturing to local cosmetic
manufacturers.
Article 6. Forms of issuance of
Certificates of eligibility for cosmetic manufacturing
1. A Certificate
of eligibility for cosmetic manufacturing shall be issued in the
following cases:
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
b) A cosmetic manufacturer that
has Certificate of eligibility for cosmetic manufacturing
issued moves its production location;
c) A cosmetic manufacturer that has
Certificate of eligibility for cosmetic manufacturing issued supplements
its production line other than that stated in the issued Certificate
of eligibility for cosmetic manufacturing.
2. The re-issuance of Certificates of eligibility for cosmetic manufacturing shall be applied
to the cases where the issued Certificates of eligibility for
cosmetic manufacturing are lost or damaged.
Article 7. Application for
issuance/re-issuance of Certificate of eligibility for cosmetic manufacturing
1. An application
for issuance of Certificates of eligibility for cosmetic manufacturing
shall consist of the following documents:
a) The application form for issuance of Certificate of eligibility for cosmetic manufacturing using Form No. 02 in the Annex enclosed with this Decree;
b) The site plans and design
drawings of the cosmetic manufacturer;
c) The list of existing
equipment of the cosmetic manufacturer;
d) The list of types of cosmetic products which are
undergoing the production or will be produced, and quality standards of each
product type.
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
a) The application form for re-issuance
of Certificate of eligibility for cosmetic manufacturing using
Form No. 03 in the Annex enclosed with this Decree;
b) The original of Certificate of
eligibility for cosmetic manufacturing (if any).
3. The said documents must be fan-stamped by the
cosmetic manufacturer and make up 01 set of the application dossier for issuance/re-issuance of Certificate of eligibility for cosmetic
manufacturing.
Article 8. Receipt of
application for issuance/re-issuance of Certificate of eligibility for cosmetic
manufacturing
1. The application shall be, by hand or by post, submitted to Department of Health where the cosmetic manufacturer’s workshop is located.
2. Within 02 working days from
the receipt of the application for issuance/re-issuance of
Certificate of eligibility for cosmetic manufacturing, Department of
Health shall check the application and perform one of the following acts:
a) Issue a Receipt note according
to the Form No. 05 in the Annex enclosed
with this Decree if the application is sufficient and valid as referred
to in Article 7 herein;
b) Make a written notice of insufficient or invalid
contents.
Article 9. Procedures for
issuance of Certificate of eligibility for cosmetic manufacturing
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
2. Within 30 working days from the
receipt of the valid application and appraisal fees
as regulated, Department of Health shall inspect the
cosmetic manufacturer and issue Certificate of eligibility for
cosmetic manufacturing to that cosmetic manufacturer. In case the
application is rejected or there are rectifications to be made by the
applicant, Department of Health shall give a written notice to specify reasons
thereof or a written request for change or remedy.
3. In cases where the cosmetic
manufacturer is requested to make certain rectifications:
a) The cosmetic manufacturer must make
rectifications and send rectification report to Department of Health;
b) Department of Health shall examine the cosmetic
manufacturer’s report, compare with the application or carry out re-inspection
of the cosmetic manufacturer’s base (where necessary). Within 15 days from the
receipt of the report on remedial results, the inspection agency must provide
inspection results in writing;
c) Within 06 working days from the date
on which the written request for rectifications is sent to the cosmetic
manufacturer, if that cosmetic manufacturer fails to submit the report on
remedial results to Department of Health, the submitted
application for issuance of Certificate of eligibility for
cosmetic manufacturing shall be invalid.
4. With regard to cosmetic manufacturers that have “Cosmetic Good Manufacturing
Practices (CGMP-ASEAN)” Certificates
granted by Ministry of Health:
a) Ministry of Health shall send official
dispatches to Departments of Health where
workshops of such cosmetic manufacturers are located with respect to the
issuance of Certificates of eligibility for
cosmetic manufacturing;
b) Within 05 working days from
the receipt of the official dispatch sent by Ministry of Health, Departments of Health shall issue Certificates of eligibility for cosmetic manufacturing to such cosmetic
manufacturers.
Article 10. Procedures for
re-issuance of Certificate of eligibility for cosmetic manufacturing
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Article 11. Amendment of
Certificate of eligibility for cosmetic manufacturing
1. The cosmetic manufacturer
that has a Certificate of eligibility for cosmetic manufacturing issued
but has change of its name or address due to change of administrative
division (the production location is unchanged) shall apply for the
amendment of Certificate of eligibility for cosmetic
manufacturing.
2. The cosmetic manufacturer
shall apply 01 set of the application for amendment of Certificate of eligibility for cosmetic manufacturing,
including the following documents:
a) The application form for amendment
of Certificate of eligibility for cosmetic manufacturing using
Form No. 04 in the Annex enclosed with this Decree;
b) Documents proving changes.
3. The application for amendment of
Certificate of eligibility for cosmetic manufacturing shall be received
and handled in compliance with regulations in Article 8 of this
Decree.
4. Within 05 working days from the
date on which Department of Health receives the application for amendment submitted by the relevant cosmetic manufacturer, Department of Health
shall issue Certificate of eligibility for cosmetic manufacturing using Form
No. 01 in the Annex enclosed with this Decree, in which, the certificate
number shall be the same with that of initially issued certificate and the time
of amendment, date and reasons of amendment shall be specified.
Article 12. Revocation of Certificate
of eligibility for cosmetic manufacturing
Certificates of eligibility for
cosmetic manufacturing shall be revoked by the issuing authorities in
the following cases:
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
2. A Certificate
of eligibility for cosmetic manufacturing has been issued by an
incompetent authority or includes unlawful contents;
3. A cosmetic manufacturer runs
its operations at a location other than that stated in the issued Certificate of eligibility for cosmetic manufacturing;
4. The application
for issuance/re-issuance/amendment of Certificate of
eligibility for cosmetic manufacturing has been forged;
5. A cosmetic manufacturer voluntarily
applies for the revocation of Certificate of
eligibility for cosmetic manufacturing.
Article 13. Fees for
appraising standards and conditions for cosmetic manufacturing
A cosmetic manufacturer that submits the application for issuance of Certificate
of eligibility for cosmetic manufacturing must pay fees for appraising
standards and conditions for cosmetic manufacturing in accordance with
regulations and laws on fees and charges.
Chaprter IV
IMPLEMENTATION
Article 14.
Effect
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Article 15.
Transitional provision
1. Cosmetic manufacturers
which have operated before the effective date of this Decree may continue their
operations to make types of cosmetic products with effective receipt number
of the Notification of cosmetic products provided that the procedures
for issuance of Certificate of eligibility for cosmetic manufacturing must be made as referred to in this Decree before
December 31, 2018.
2. If cosmetic
manufacturers which have operated before the effective date of this Decree want
to produce types of cosmetic products other than those
being issued with receipt number of the Notification of cosmetic
products, they must carry out the procedures for issuance
of Certificate of eligibility for cosmetic manufacturing as referred to in this
Decree before starting that production of new types of cosmetic
products.
3. Ministry of Health shall
provide the list of cosmetic manufacturers to which it has
granted “Cosmetic Good Manufacturing Practices (CGMP-ASEAN)” Certificates before the effective date of this
Decree to Departments of Health in order to issue Certificates of eligibility for cosmetic manufacturing to them
before December 31, 2016.
4. During their operation, cosmetic manufacturers shall adopt the quality management system
in compliance with “Cosmetic Good Manufacturing Practices
(CGMP-ASEAN)” guidelines and standards.
Article 16. Implementation
organization
1. Minister of Health shall be
responsible for organizing and guiding the implementation
of this Decree.
2. Ministers, heads of
ministerial-level agencies, heads of affiliates of the Government and chairpersons of people’s committees of central-affiliated
cities or provinces shall be responsible for implementing
this Decree./.
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
ON BEHALF OF
THE GOVERNMENT
PRIME MINISTER
Nguyen Xuan Phuc
ANNEX
(Enclosed to the
Government’s Decree No. 93/2016/ND-CP
dated July 01, 2016)
Form No. 01
Certificate of eligibility for
cosmetic manufacturing
Form
No. 02
Application form for issuance of Certificate
of eligibility for cosmetic manufacturing
Form
No. 03
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Form
No. 04
Application form for amendment
of Certificate of eligibility for cosmetic manufacturing
Form
No. 05
Application receipt note
Form No. 01
PEOPLE’S COMMITTEE
OF PROVINCE
DEPARTMENT OF HEALTH
-----------
SOCIALIST
REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
-----------
No.: ………………..
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
CERTIFICATE OF ELIGIBILITY FOR COSMETIC MANUFACTURING
(*)
Initial certificate
is issued on………………………..[date]
Time of
amendment:…….., made on………., reasons of amendment:……………..
- Pursuant to the Government’s Decree No………………. providing for conditions for manufacture
of cosmetic products;
- Pursuant
to……………….defining functions and tasks of……………..
- At the request of ……………..
(NAME OF ISSUING
AUTHORITY) HEREBY CERTIFIES
(**) …………………………………………………………………………………………….
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Has satisfied all conditions for manufacture of cosmetic products
Production lines
consist of:………… (***)
……..[place],……………………[date]
DIRECTOR
(Signature, seal and full name)
(*) In case of re-issuance, the phrase “BẢN CẤP LẠI” (RE-ISSUANCE) must be specified.
(**) Name of
cosmetic manufacturer which is stated in the application for issuance of Certificate of eligibility for cosmetic manufacturing is
specified.
(***) All production lines are
specified, consisting of: Product packaging line; production line for producing
semi-finished products in dry; production line for producing semi-finished
products in wet form; production line for producing finished products in dry or
wet or other form.
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Form No. 02
NAME OF
COSMETIC MANUFACTURER
--------
SOCIALIST
REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
-----------
…………….[place],…………….[date]
APPLICATION FORM FOR ISSUANCE OF CERTIFICATE OF ELIGIBILITY FOR
COSMETIC MANUFACTURING
To: ……………..
Name of cosmetic manufacturer:
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Number of business registration certificate, issued
date and issuing authority:
Phone
number:
Fax: E-mail:
Pursuant to the Government’s Decree No……………………dated…………………..providing
for conditions for manufacture of cosmetic products, the cosmetic
manufacturer…………….does request Department of Health…………to issue Certificate of
eligibility for cosmetic manufacturing (production lines consist of:…… (*)), this application includes the following documents:
1. The site plans
and design drawings of factory;
2. The list of existing
equipment in the factory;
3. The list of cosmetic
products which are producing and/or will be produced; quality standards of each
type of cosmetic products.
The cosmetic manufacturer…………commits that all
contents stated herein are true and authentic, and this cosmetic manufacturer
shall bear responsibility for declared contents.
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
(*) Names of
production lines must be specified, consisting of: Product
packaging line; production line for producing semi-finished products in dry
form; production line for producing semi-finished products in wet form; production
line for producing finished products in dry or wet or other form.
Form
No. 03
NAME OF
COSMETIC MANUFACTURER
--------
SOCIALIST
REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
-----------------
…………….[place],…………….[date]
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
To:
……………..
Name of cosmetic manufacturer:
Address:
Number of business registration
certificate, issued date and issuing authority:
Phone number:
Fax: E-mail:
Pursuant to the Government’s Decree
No…………………dated………………..providing for conditions for manufacture of cosmetic
products, the cosmetic manufacturer…………….does request Department of
Health…………to re-issue Certificate of eligibility for
cosmetic manufacturing on the basis of the issued Certificate
of eligibility for cosmetic manufacturing No......., issued
on...........[date]
Reason for re-issuance: ……… (*)
The cosmetic manufacturer…………commits
that all contents stated herein are true and authentic, and this cosmetic
manufacturer shall bear responsibility for declared contents.
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
DIRECTOR
OF COSMETIC MANUFACTURER
(Signature, full name and seal)
(*) Reasons for re-issuance
must be specified as: Loss or damage.
Form No. 04
NAME OF
COSMETIC MANUFACTURER
--------
SOCIALIST
REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
-----------------
…………….[place],…………….[date]
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
APPLICATION FORM FOR AMENDMENT OF CERTIFICATE OF ELIGIBILITY FOR
COSMETIC MANUFACTURING
To:
……………..
Name of cosmetic manufacturer:
Address:
Number of business registration
certificate, issued date and issuing authority:
Phone number:
Fax: E-mail:
Pursuant to the Government’s Decree
No…………………dated………………..providing for conditions for manufacture of cosmetic
products, the cosmetic manufacturer…………….does request Department of
Health…………to amend the Certificate of eligibility for
cosmetic manufacturing on the basis of the Certificate of eligibility for
cosmetic manufacturing No......., issued by Department of
Health on...........[date]
Reasons for amendment: …..…… (*)
The cosmetic manufacturer…………commits that
all contents stated herein are true and authentic, and this cosmetic
manufacturer shall bear responsibility for declared contents.
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
DIRECTOR
OF COSMETIC MANUFACTURER
(Signature, full name and seal)
(*) Reasons for amendment must be specified: Change
of cosmetic manufacturer’s name or address due to change of administrative
division.
Form No. 05
PEOPLE’S COMMITTEE
OF PROVINCE……
DEPARTMENT OF HEALTH
-----------
SOCIALIST
REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
-----------------
No.
/PTN-
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
APPLICATION RECEIPT NOTE
Full name of receiver:
Position, working unit:
Has received the application (*)……..submitted by
the cosmetic manufacturer:…….
The application consists of the following documents:
1...
2...
3...
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
RECEIVER
(Signature, full name and seal)
(*) The application for issuance,
or re-issuance, or amendment of Certificate
of eligibility for cosmetic manufacturing must be specified.